Protocol summary

Study aim
Determine the effect of sexual counseling by smartphone on sexual intimacy of women with breast cancer referring to Cancer Institute of Tehran Imam Khomeini Hospital2017-2018
Design
In this study, 60 women eligible for breast cancer were randomly assigned to two groups of intervention and control.The sample size is similar to other related studies, considering α = 05% and α = 2%, and the average changes (standard deviation). The score of sexual intimacy in the intervention and control groups is 6.6 (5.2) and 0.5 (10.80), respectively in the intervention and control group. Number of participants in both groups will be 35 individuals considering 10% loss in both groups that will make it to 30 induvial.
Settings and conduct
Design :It is a randomized controlled clinical trial without blinding. setting and conduct: Cancer Center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
participants:the sample cinsisted of 20to60 women with breast cancer who have had amastectomy. Entry criteria: Women aged 20 to 60 years old, being married, women with breast cancer who have had mastectomy, lack of prosthesis, having reading and writing skills, absence of chronic diseases (cardiac, diabetes, kidney, liver), having medium-to-low score based on sexual intimacy questionnaire, access to smartphone and internet, ability to use smartphone, and spouse consent. Exclusion criteria: Unwilling to continue participating in the study, not attending the maximum of two counseling sessions, history of notable physical and psychological illnesses such as psychotic disorders including schizophrenia and severe depression, the occurrence of stressful events (death of close relatives, divorces, etc) during the study, drug abuse or addiction, being divorced or widowed.
Intervention groups
Intervention group: In this group, gender related counseling along with routine consultation related to mastectomy and chemotherapy will be provided twice a week via a telegram channel, which will allow people to enter into discussions and express their opinions. The telegram channel (for a period of one month consisting of 6 counseling sessions twice weekly) will be directed by the Admin and relevant contents will be posted. To ensure that the participants use the topics that are presented in the telegram in each session, several questions will be developed by the researcher related to the subject of each session and will be asked privately after each meeting. The meetings are as follows: Session 1: Welcoming the group, introducing the participant, determining how to make relationship, the importance of marital relationships, sexual education and marital affairs. Session 2: Teaching the right techniques of sexual relation. Session 3: Introduction to the common sexual disorders of women. Session Four: Introduction to the physiology of sexual intercourse and behavior using body picture. Session 5: Training concentration skills, awareness of sensory symptoms, expression of excitement, and sexual self-expression. Session 6: Confronting negative and non-rational thoughts and reviewing the previous sessions
Main outcome variables
sexual intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160503027728N6
Registration date: 2018-01-10, 1396/10/20
Registration timing: prospective

Last update: 2018-01-10, 1396/10/20
Update count: 0
Registration date
2018-01-10, 1396/10/20
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sexual counseling by smartphone on sexual intimacy of women with breast cancer referring to Cancer Institute of Tehran Imam Khomeini Hospital2017-2018
Public title
Investigating the effect of sexual counseling by smartphone on sexual intimacy of women with breast cancer referring to Cancer Institute of Tehran Imam Khomeini Hospital2017-2018
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria: Women aged 20 to 60 years old being married women with breast cancer who have had mastectomy lack of prosthesis having reading and writing skills absence of chronic diseases (cardiac, diabetes, kidney, liver) having medium-to-low score based on sexual intimacy questionnaire access to smartphone and internet ability to use smartphone and spouse consent
Exclusion criteria:
Exclusion criteria: Unwilling to continue participating in the study,, , , divorces, etc) during the study not attending the maximum of two counseling sessions history of notable physical and psychological illnesses such as psychotic disorders including schizophrenia and severe depression the occurrence of stressful events (death of close relatives drug abuse or addiction being divorced or widowed
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
This is a randomized controlled clinical trial that will be conducted on women with breast cancer who have undergone mastectomy in 2017-18, based on randomized blocks in two groups of intervention and control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz university of medical sciences
Street address
Karaj - Taleghani Square, North Taleghani Blvd, Administrative City, Alborz University of Medical Sciences
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
Abzums.Rec.1396.147

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
sexual intimacy questionnaire score
Timepoint
befor intervention and at the end of the consultation session
Method of measurement
sexual intimacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, gender related counseling along with routine consultation related to mastectomy and chemotherapy will be provided twice a week via a telegram channel, which will allow people to enter into discussions and express their opinions. The telegram channel (for a period of one month consisting of 6 counseling sessions twice weekly) will be directed by the Admin and relevant contents will be posted. To ensure that the participants use the topics that are presented in the telegram in each session, several questions will be developed by the researcher related to the subject of each session and will be asked privately after each meeting.
Category
Other

2

Description
Control group: In the control group, they will receive routine consultation related to mastectomy and chemotherapy through the telegram channel. In order to comply with the ethics of the weekly, after completing the consultation, they will receive an educational package related to sexual intimacyt (all the materials presented in the intervention group)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Center of Tehran Imam Khomeini Hospital
Full name of responsible person
Dr.Zohreh Mahmoodi
Street address
End of Farmer Blvd. Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1526
Email
hosp-cancer@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blvd, Corner of Quds Street, Central University
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Departement of Nursing Alborz university of Medical Science Eshteraki st Baghestan Blv karaj
City
karaj
Province
Alborz
Postal code
56131452
Phone
+98 26 3433 6007
Email
fnm@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Departement of Nursing Alborz University of Medical Science Eshteraki st Baghestan Blv karaj
City
karaj
Province
Alborz
Postal code
56131452
Phone
+98 26 3433 6007
Email
fnm@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.Zohreh Mahmoodi
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Departement of Nursing Alborz University of Medical Science Eshteraki st Baghestan Blv karaj
City
karaj
Province
Alborz
Postal code
56131452
Phone
+98 26 3433 6007
Email
fnm@abzums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data will be published as an article
When the data will become available and for how long
10 mounts after publication
To whom data/document is available
This is only available for for people working in academic institutions or people working in businesses
Under which criteria data/document could be used
path analysis
From where data/document is obtainable
Dr. Zohreh Mahmoodi
What processes are involved for a request to access data/document
send an email to Dr. Zohreh Mahmoodi
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